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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 814 - PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart A [§ 814.1 - § 814.19] - Subpart A—General
Subpart B [§ 814.20 - § 814.39] - Subpart B—Premarket Approval Application (PMA)
Subpart C [§ 814.40 - § 814.47] - Subpart C—FDA Action on a PMA
Subpart D - Subpart D—Administrative Review [Reserved]
Subpart E [§ 814.80 - § 814.84] - Subpart E—Postapproval Requirements
Subpart F - Subparts F-G [Reserved]
Subpart H [§ 814.100 - § 814.126] - Subpart H—Humanitarian Use Devices
authority:
21 U.S.C. 351
,
352
,
353
,
360
,
360
c-360j,
360
bbb-8b,
371
,
372
,
373
,
374
,
375
,
379
,
379
e,
379
k-1,
381
source:
51 FR 26364, July 22, 1986, unless otherwise noted.
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